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Evaluation of the Effectiveness of a Program on Service Process in Outpatient Pharmacies

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ClinicalTrials.gov Identifier: NCT03388567
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Pedro Amariles, Universidad de Antioquia

Brief Summary:

Preventable failures in the drug chain are related to Drugs Problems Related Use and are associated with medication errors (prescription, dispensing, administration or use by the patient or caregiver), including failures In the Medication Supply System (availability and quality).

The controlled drugs are those that contain substances regulated by international conventions on drug control. They are important in various fields of medicine, such as pain management, obstetric emergencies, mental disorders such as the treatment of substance dependence, psychiatry and neurology. It has been defined as abuse of drugs the improper use of these for non-medical purposes, and associated with the use without medical prescription, which can produce addiction or psychic or physical dependence.


Condition or disease Intervention/treatment Phase
Controlled Drug Dependence Other: Staff pharmacy whith intervention Not Applicable

Detailed Description:
Experimental study with random assignment of the staff pharmacist of Pharmacies. The staff pharmacists admitted will be followed for 12 months (1 year). The study will make it possible to determine the effect of the continuing education program accompanied by Information and Communication Technologies (ICT).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Effectiveness of a Program on Service Process of Dispensation, Health Education and Pharmacovigilance of Controlled Drugs in Outpatient Pharmacies: A Multicenter, Cluster-Randomized, Controlled Trial
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Staff pharmacy whith intervention
Staff pharmacy who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist
Other: Staff pharmacy whith intervention
Pharmacists who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist

No Intervention: Staff pharmacy without intervention
Staff pharmacy who will receive only pharmacy information



Primary Outcome Measures :
  1. Pharmacy staff competences (Pharmacy staff knowledge, skills and attitudes. ) [ Time Frame: 12 months ]

    Pharmacy staff knowledge, skills and attitudes.

    An adapted and self-designed questionnaire is used from different bibliographical references, among them, the General Level Framework (GLF), as well as the guidelines of the Colombian legislation for pharmacy staff competences. The main areas of competency (competency clusters): which are:

    • Delivery of patient care
    • Personal
    • Problem Solving
    • Management and Organisation

    The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:

    • Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)
    • Sometimes: Much more haphazard than "usually" (21-50 %)
    • Usually: Implies standard practice with occasional lapses (51-84 %)
    • Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)


Secondary Outcome Measures :
  1. Characterize the processes associated with the use of medications in the Pharmaceutical Establishments [ Time Frame: 2 months ]

    Recognize basic information of the Pharmaceutical Establishments (PE), to characterize some processes related to the use of controlled drugs (CD), including compliance with the regulations, and determine the level of risk perception and the continuing education needs of the pharmacy staff. An adapted and self-designed questionnaire is used from different bibliographical references.

    The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:

    • Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)
    • Sometimes: Much more haphazard than "usually" (21-50 %)
    • Usually: Implies standard practice with occasional lapses (51-84 %)
    • Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)

  2. Implementation of pharmaceutical professional services [ Time Frame: 12 months ]

    Measure the degree of implementation of pharmaceutical professional services: Dispensation, Health Education and Pharmacovigilance services. An adapted and self-designed questionnaire is used from different bibliographical references, among them, the guidelines of the Colombian legislation for the development of pharmaceutical services.

    The assessment rating is on a 4-point scale ranging from rarely, sometimes, usually to consistently:

    • Rarely: Very rarely meets the standard expected. No logical thought process appears to apply (0-20 %)
    • Sometimes: Much more haphazard than "usually" (21-50 %)
    • Usually: Implies standard practice with occasional lapses (51-84 %)
    • Consistently: Demonstrates the expected standard of practice with very rare lapses (85-100 %)

  3. Satisfaction level pharmacy staff [ Time Frame: 12 months ]

    Pharmacy staff satisfaction about the continuing education program. An adapted and self-designed questionnaire is used from different bibliographical references, among them, the General Level Framework (GLF), as well as the guidelines of the Colombian legislation for the development of labor competences from the pharmaceutical services.

    A five points scale (5=Excellent, 4=Good, 3=Satisfactory, 2=Needs Improvement, and 1=Unacceptable) will used in the questionnaire.


  4. Satisfaction level patients [ Time Frame: 12 months ]

    Patients satisfaction of pharmacy professional services. An adapted and self-designed questionnaire is used from different bibliographical references.

    A five points scale (5=Excellent, 4=Good, 3=Satisfactory, 2=Needs Improvement, and 1=Unacceptable) will used in the questionnaire




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pharmacy staff working in Pharmacy or Drugstore, located geographically in the city of Medellín and in the Metropolitan Area
  2. That the owner works in the establishment

Inclusion Exclusion:

1. Pharmacy staff who do not agree to participate in the study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388567


Contacts
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Contact: Mauricio Ceballos, MsC 057-3174268448 javier.ceballos@udea.edu.co

Locations
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Colombia
Universidad de Antioquia Recruiting
Medellín, Antioquia, Colombia, 1226
Contact: Mauricio Ceballos, MsC    057-3174268448    javier.ceballos@udea.edu.co   
Contact: Pedro Amariles, PhD    057-2195476    pedro.amariles@udea.edu.co   
Sponsors and Collaborators
Universidad de Antioquia
Investigators
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Principal Investigator: Pedro Amariles, PhD Universidad de Antioquia

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Responsible Party: Pedro Amariles, Investigador principal, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT03388567     History of Changes
Other Study ID Numbers: 0017102017MC
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pedro Amariles, Universidad de Antioquia:
Dispensation
Health Education
Pharmacovigilance
Pharmacists

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders